- Expanded clinical trial program with ADSTILADRIN starts up in the United States
- Current clinical trial program of five multi-year studies to evaluate ADSTILADRIN demonstrate Ferring’s commitment to improve outcomes for patients across the spectrum of urothelial cancers
- Research will enlarge the body of evidence for ADSTILADRIN, the first and only FDA-approved intravesical non-replicating gene therapy for NMIBC
“ADSTILADRIN is the foundation of Ferring’s leadership mission in the uro-oncology therapeutic category and our ambition is for it to become the new standard of care and the backbone therapy for patients across the NMIBC disease spectrum,” said Bipin Dalmia, Senior Vice President, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Embarking on a broad research and geographic expansion program is yet another demonstration of our commitment to the uro-oncology community, together with our significant manufacturing investments that recently enabled full availability of ADSTILADRIN to every appropriate U.S. patient who needs it.”The addition of three new ABLE clinical trials to the existing multi-year ADSTILADRIN studies program will expand the body of evidence for the intravesical non-replicating gene therapy:
- ABLE-22: A Phase 2, randomized, multi-center, open label clinical study to evaluate the safety and efficacy of ADSTILADRIN alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in adult patients with high-grade BCG-unresponsive NMIBC.
- ABLE-32: A Phase 3b randomized, controlled clinical study to evaluate the safety and efficacy of ADSTILADRIN versus observation in patients with intermediate-risk NMIBC.
- ABLE-42: A Phase 4, multi-center, open-label clinical study to evaluate the efficacy of retreatment with ADSTILADRIN in previously-treated patients with high-grade BCG-unresponsive NMIBC with CIS with or without papillary tumors who had not responded to the product at the first three-month assessment.
The ADSTILADRIN clinical trial program includes two additional studies, the first being ABLE–41, a U.S. Real-World Evidence (RWE) Study announced in September 2023 and the second being a bridging study in Japan. The ABLE-22, ABLE-32 and ABLE-42 clinical trials announced today are yet another milestone for this comprehensive research program.
“ADSTILADRIN is an established monotherapy treatment option for patients with BCG-unresponsive NMIBC disease, an area where patients’ treatment options have been severely limited for decades,” said Pierre-Yves Berclaz, M.D., Ph.D., Executive Vice President and Chief Science and Medical Officer, Ferring Pharmaceuticals. “These new trials underscore Ferring’s commitment to create solutions for patients by enlarging the body of evidence for this novel nonreplicating gene therapy.”
Additional ongoing studies in the ADSTILADRIN clinical trial program include:
- ABLE-41 (NCT06026332): An ongoing, non-interventional RWE study following NMIBC patients aged 18 years or older with high-risk, BCG-unresponsive NMIBC who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. The study is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting in these patients. The first patient was enrolled in September 2023.
- Japan Phase 3B Study (000381): Single arm bridging study of high grade, BCG-unresponsive NMIBC patients.